Eastern Oklahoma Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/08, 09, 10, 11/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the Quality Director, Laboratory Manager, Chief Operating Officer, Chief Nursing Officer, and Chief Executive Officer during an exit conference performed at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with technical supervisor #2 and quality director, the laboratory failed to have a written policy to assess the competency of the technical supervisor, based on the position responsibilities as listed in Subpart M, for one of one person requiring a competency assessment. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical supervisor, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of November 2023 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person requiring a competency assessment; 3) The findings were reviewed with technical supervisor # 2 and quality manager who stated on 07/09 /2025 at 02:15 pm, a policy had not been written, and competencies had not been performed for the position as stated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with technical supervisor #2, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 07/08/2025 at 10:10 am, identified the following expired supplies were available for use: (a) Four BD Vacutainer PST Gel and Lithium Heparin 83 Units, Lot 4166559, Exp. 06/30/2025 (b) One BD Vacutainer Buff. Na Citrate 0.109M, 3.2%, Lot 4344926 Exp. 06/30/2025 (c) One BD Microtainer MAP K2E (1.0mg), Lot 3324804, Exp. 05/31/2025 (2) Interview with technical supervisor #2 on 07/09/2025 at 1:30 pm confirmed the expired supplies were available for use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, and Performance Summary and Comparative Evaluations obtained from American Proficiency Institute, the laboratory failed to successfully participate in a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for pO2 Blood Gas. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte pO2 Blood Gas in two consecutive testing events. Findings include: (1) The laboratory received a score of 0% on the first 2024 event and a score of 60% on the second 2024 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte pO2 Blood Gas in two consecutive events. The laboratory failed to achieve a passing score of 80% for the first and second 2024 events. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte pO2 Blood Gas in two consecutive events. The laboratory failed to achieve a passing score of 80% for the first and second 2024 events. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/30/2023 through 11/01/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief nursing officer, chief executive officer, chief operating officer, general supervisor #1 and general supervisor #2 during an exit conference performed at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with general supervisor #1 and general supervisor #2, the laboratory failed to follow their written procedure for CBC (Complete Blood Count) testing for one of five patient reports. Findings include: (1) On 10/30/2023 at 10:20 am, general supervisor #1 and general supervisor #2 stated CBC (Complete Blood Count) testing was performed on the Sysmex XN1000 hematology analyzer; (2) A review of the manual titled, "Laboratory Policy and Procedure Manual" under the hematology procedure, titled, "Manual Differential/Blood Smear Review" stated the following as guidance for when to perform a manual differential or slide review: (a) "For WBC IP Messages: - If there is an Asterisk (*) next to numerical results:" (i) Prepare, stain, and scan a peripheral smear for the presence of any immature, atypical or abnormal cells or clumped platelets; (ii) If NO abnormalities are noted, the instrument results may be reported. A comment must be entered into the LIS that a blood smear was reviewed, and no abnormalities were found; (iii) If abnormalities are noted on the blood smear review, a manual differential will be ordered in the LIS, performed and reported." (3) A review Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- of five patient records meeting the criteria for a manual differential or slide review identified no evidence the laboratory followed their written procedure for one of five patient records as follows: (a) Patient tested on 10/27/2023 at 01:03 pm with a WBC IP Message of "Atypical Lympho?" obtained. There was no evidence a blood smear had been reviewed for this flag. (4) The findings were reviewed with general supervisor #1 and general supervisor #2 who stated on 10/31/2023 at 01:50 pm that the procedure had not been followed as indicated above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation and interview with general supervisor #1, the laboratory failed to ensure four of four types of blood collection tubes were stored as required by the manufacturer, in a room denoted as the supply room. Findings include: (1) Observation of the central supply room and interview with general supervisor #1 on 10 /30/23 at 10:25 am, identified the following: (a) 400 BD Vacutainer EDTA tubes, lot # 31111796, storage temperature of 4-25 degrees Celsius; (b) 300 BD Vacutainer serum tubes, lot # 3123504, storage temperature of 4-25 degrees Celsius; (c) 200 BD Vacutainer lithium heparin tubes, lot # 367884, storage temperature of 4-25 degrees Celsius; (d) 200 BD Vacutainer buffered sodium citrate heparin tubes, lot # 3163627, storage temperature of 4-25 degrees Celsius. (2) Interview with general supervisor #1 on 10/30/2023 at 10:25 am confirmed the laboratory was not monitoring the temperature of the supply room. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/27,28,29/2021 The findings were reviewed with the laboratory director, laboratory manager, chief financial officer, chief operational officer, and chief nursing officer during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.801; D2000: Enrollment and Testing of Samples 493.1447; D6108: Technical Supervisor D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to enroll in a proficiency testing program for qualitative serum pregnancy testing. Findings include: (1) On 10/27/2021 the surveyor reviewed proficiency testing records for 2020 (first, second and third events), 2021 (first, and second events). There was no evidence the laboratory was enrolled in proficiency testing for serum qualitative pregnancy testing for 5 of 5 events; (2) On 10/28/2021, the surveyor reviewed the records with the laboratory manager who stated on 10/28 /2021 at 09:32 am the laboratory was not enrolled in proficiency testing for serum qualitative pregnancy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to follow their function check protocol for ensuring the chemistry and coagulation centrifuges were functioning properly for one of two function checks. Findings include: (1) On 10/28/2021 at 02:45 pm, the laboratory manager stated the following to the surveyor: (a) The laboratory performed routine chemistry testing using the OrthoVitros 5600 analyzer; (i) The specimens were processed in the Drucker 755V (serial number 510909) centrifuge at a speed of 32000 rpm (Revolutions Per Minute) and a time of 10 minutes; (b) The laboratory performed routine coagulation testing using the Sysmex CA6000 series analyzer; (i) The specimens were processed in the Iris Stat Spin (serial number 1206m50204643) centrifuge at a speed of 7200 RPM for 3 minutes. (2) The surveyor asked the laboratory manager to explain how often function checks (speed and timer checks) were performed on the centrifuges. The laboratory manager stated on 10/28/2021 at 02:55 pm it was the laboratory's policy to check the speed and timer of the centrifuges annually; (3) The surveyor reviewed the centrifuge function check records that had been performed in 2020 and 2021. The centrifuge time had been checked as follows: (a) Drucker 755V chemistry centrifuge (i) 05/04/2020 for 5 minutes (b) Iris Stat Spin coagulation centrifuge (i) 10/02/2020 for 5 minutes (4) The surveyor reviewed the records with the laboratory manger and asked if the timer had been checked at a time of 10 minutes and three minutes according to the laboratory's policy for performing routine chemistry and coagulation testing. The laboratory manager stated on 10/28 /2021 at 03:25 pm, the checks had not be checked at 10 minutes and 3 minutes. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to make appropriate reference ranges available for one of one reagent lot number change. Findings include: (1) On 10/27/2021 at 03:30 pm, the laboratory manager stated to the surveyor the laboratory performed PTT (Partial Thromboplastin Time) testing on the Sysmex CA-600 analyzer. In addition the following reagent was put into use on 03/07/2021: (a) Dade Actin PTT reagent lot #526613 (2) On 10/28 /2021, the surveyor reviewed the PTT reagent implementation records and identified -- 2 of 10 -- the laboratory had verified a PTT normal reference interval of 21.49 - 28.73 seconds; (3) The surveyor then reviewed a patient PTT report dated 10/10/2021 at 03:38 pm with a normal reference range of 22.60 - 32.10 seconds; (4) The surveyor surveyor reviewed the findings with the laboratory manager. On 10/28/2021 at 02:14 pm, the laboratory manager stated that although the laboratory had established a PTT normal reference interval with the PTT reagent lot change, the laboratory had not implemented the change into the laboratory's computer information system. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with laboratory manager, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. Refer to D6111. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, -- 3 of 10 -- physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) -- 4 of 10 -- (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) -- 5 of 10 -- Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the -- 6 of 10 -- specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) -- 7 of 10 -- An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- -- 8 of 10 -- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical supervisor failed to ensure that individuals who performed the duties and responsibilities of the technical supervisor met the qualifications for 1 of 1 of semiannual competency assessments. Findings include: (1) On 10/27/2021, the surveyor reviewed records for 1 testing person who had been hired to perform high complexity testing (ABO/Rh, Antibody Screen and Compatibility testing) since the previous recertification survey performed. The records indicated the semi-annual -- 9 of 10 -- evaluation for the testing person had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #8 - The 03/31/2021 semi-annual evaluation had been performed by the laboratory manager (this person had earned a bachelor degree in applied science). (2) The surveyor explained to the laboratory manager that all components of the semi- annual competency evaluations must be performed by a person who qualifies as a technical supervisor (493.1449 (q) an individual with an MD or DO with a current medical license in state of laboratory's location and certified in anatomic pathology by ABP or AOBP or equivalent qualifications or resident in a program leading to ABP or AOBP certification in anatomic and clinical pathology who performs duties delegated by the technical supervisor for histopathology). On 10/27/2021 at 04:20 pm, the laboratory manager stated to the surveyor the semi-annual evaluation had not been performed by someone who met the qualifications of a technical supervisor as indicated above. NOTE: The regulations only allow for an individual qualifying as a general supervisor to perform initial training and annual competency evaluations as stated at 493.1463 "Standard; General supervisor responsibilities: (b)(3) Providing orientation to all testing personnel; and (b)(4) Annually evaluating and documenting the performance of all testing personnel" -- 10 of 10 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on 10/01/19 through 10/04/19. The findings were reviewed with chief operating officer, chief financial officer, chief nursing officer and the laboratory manager/technical consultant during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager/technical consultant, it was determined the laboratory failed to maintain patient records for at least 2 years for 3 of 8 months. Findings include: (1) On the second day of the survey, the laboratory manager/technical consultant stated CBC (Complete Blood Count) testing was performed using the Sysmex 4000 analyzer; (2) Later during the survey, the surveyor requested analyzer printouts from testing performed from 01/01/2019 through 03/16 /19, which would include morphology flags (printouts would include the following if morphology flags were present: RBC Abn Distribution, Hypochromia, Macrocytosis, NRBC, Blasts). The laboratory manager/technical consultant explained since patient information was transferred to their LIS (Laboratory Information System), the instrument printouts were not maintained before 08/30/19; (3) The surveyor then asked the laboratory manager/technical consultant how morphology flags were verified. The supervisor explained: (a) The specimen would be retested; (b) If the flags were still present, a manual differential or morphology would be performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- according to manufacturer's instructions. (4) Since the laboratory did not maintain instrument printouts, the surveyor could not determine if morphology flags had been verified as required between 01/01/19 through 03/19/19. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the laboratory failed to review and evaluate proficiency testing results for 1 of 27 events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Second 2019 Chemistry Core Event (i) Troponin - 3 of 5 results exhibited a positive bias (aa) CM-06 - SDI of 2.9 (bb) CM-07 - SDI of 2.7 (cc) CM-10 - SDI of 2.7 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the laboratory manager/technical consultant, and asked if the biases had been addressed. The laboratory manager stated the biases had not been addressed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results for 1 of 27 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Hematology (i) 2018 First Event (aa) Blood Cell Identification BC-01 (bb) Blood Cell Identification BC-06 (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded results; (3) The surveyor asked the laboratory manager/technical consultant if the results had been documented as evaluated. The laboratory manager/technical consultant reviewed the records and stated the non-graded results had not been documented as reviewed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 2 of 5 -- must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, written procedure, and interview with laboratory manager/technical consultant, the laboratory failed to demonstrate the performance specifications for a new test method. Findings include: (1) On the second day of the survey, the laboratory manager/technical consultant stated to the surveyor the laboratory began using the K-check Tablets to perform serum Ketone patient testing on 09/06/17; (2) The surveyor requested documentation from the technical consultant to substantiate the performance specifications (i.e., accuracy) had been demonstrated for the test kit before it had been put into use; (3) The laboratory manager/technical consultant stated to the surveyor, the performance specifications had not been demonstrated for the test kit. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the laboratory failed to have control procedures that monitored the accuracy and precision of the analytic process for Vitamin B12 for 7 of 7 months. Findings include: (1) On the second day of the survey, the laboratory manager /technical consultant stated the following to the surveyor: (a) Vitamin B12 testing was performed using the OrthoVitros 5600 analyzer; (b) Two levels (Level 1 and Level 3) of Bio Rad control materials were performed each day of patient testing. (2) The surveyor reviewed quality control records for testing performed between 01/01/19 through 07/31/19. A bias was identified as follows: (a) Vitamin B 12 (level 3 lot#40973) - 140 out of 161 control results were consistently above the established mean. (3) There was no evidence in the records the control biases had been identified and addressed; (4) The surveyor reviewed the records with the laboratory manager /technical consultant and asked if there was documentation to prove the bias had been identified and addressed. The laboratory manager/technical consultant stated the bias had not been addressed; (5) Since the above bias had not been identified and addressed, the surveyor determined the laboratory failed to have control procedures that monitored the accuracy of testing for the above analyte. -- 3 of 5 -- D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for 3 of 27 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records. It was identified for 3 of 27 events, the attestation statements had been signed approximately 2-4 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Hematology/Coagulation second event of 2018 - The samples had been tested on 07/17/18 and the attestation statement had not been signed by the laboratory director until 12/13/18; (b) Immunohematology second event of 2018 - The samples had been tested on 08/14/18 and the attestation statement had not been signed by the laboratory director until 12/13/18; (c) Chemistry Miscellaneous first event of 2018 - The samples had been tested on 10/25/18 and the attestation statement had not been signed by the laboratory director until 12/13/18; (2) The surveyor reviewed the findings with the laboratory manager/technical consultant and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the technical consultant failed to ensure evaluations included all moderate complexity testing performed for 7 of 7 testing persons. Findings include: (1) On the second day of the survey, the laboratory manager/technical consultant stated to the surveyor serum Ketone analysis was performed using the K-Check Tablets in the laboratory: (2) The surveyor then reviewed personnel records for 7 persons performing serum ketone analysis in the laboratory. The records verified that evaluations had been performed as follows: (a) Testing Person #1 - Performed on 01 /30/18 and 01/29/19 (b) Testing Person #2 - Performed on 01/30/18 and 01/29/19 (c) Testing Person #3 - Performed on 01/30/18 and 01/29/19 (d) Testing Person #4 - Performed on 01/30/18 and 01/29/19 (e) Testing Person #5 - Performed on 01/30/18 and 01/29/19 (f) Testing Person #6 - Performed on 01/30/18 and 01/29/19 (g) Testing -- 4 of 5 -- Person #7 - Performed on 01/30/18 and 01/29/19 (3) There was no evidence the evaluations, performed for the above persons, included an assessment of serum Ketone analysis; (4) The surveyor reviewed the findings with the laboratory manager /technical consultant, who stated the above evaluations did not include serum Ketone analysis. -- 5 of 5 --